M2A-MAGNUM 42-50MM TAPER INSERT-3
Report
- Report Number
- 0001825034-2013-00130
- Event Type
- Injury
- Date Received
- January 18, 2013
- Date of Event
- November 5, 2012
- Report Date
- January 17, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02502 & 1825034-2013-00129/00130).
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES: " INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS EVENT HAS ALREADY BEEN REPORTED ON MEDWATCH 0001825034-2012-02502. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL ALLEGED FURTHER ISSUES WHICH NECESSITATED THAT ADDITIONAL MEDWATCH REPORTS BE SUBMITTED. THIS EVENT IS BEING REPORTED ON THREE MEDWATCHES (REFERENCE 0001825034-2012-02502 / 0001825034-2013-00129 & 00130.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT A M2A HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2012. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES PAIN, INFLAMMATION, COMPLICATIONS WITH HIP POPPING, DISLOCATION, AND DIFFICULTY WITH MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO METALLOSIS, PAIN, LACK OF MOBILITY, CYSTS AND BONE LOSS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORTS IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT A M2A HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2012. PATIENT'S LEGAL COUNSEL ALLEGES PAIN, INFLAMMATION, COMPLICATIONS WITH HIP POPPING, DISLOCATION, AND DIFFICULTY WITH MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THIS REPORTS IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27984 | M2A-MAGNUM 42-50MM TAPER INSERT-3 | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 347190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R |